Vapor hydration of a hydrophilic catheter in a package

ABSTRACT

A vapor hydrated packaged catheter assembly and method of manufacturing and distributing same includes a gas impermeable package housing a catheter within a catheter-receiving cavity. The catheter assembly has a hydrophilic coating applied to at least a portion of the outer surface of a catheter tube or shaft which may be surrounded by a sleeve to provide a no-touch, sure grip feature. The catheter assembly is disposed within the catheter receiving cavity of the package together with a limited amount of a vapor donating liquid provided as a source of vapor to activate the hydrophilic coating. The amount of vapor donating liquid is less than the amount that would otherwise be sufficient to cause a spill hazard. It may be loose liquid as a desired percentage of the volume of a tube-receiving portion of the catheter receiving cavity of the package, or it may be contained in a liquid sequestering element. The activation of at least some of the hydrophilic coating occurs solely by reason of exposure of the outer surface of the catheter to a vapor produced by the vapor donating liquid. The distribution of the catheter following manufacture is delayed for a time sufficient to permit the vapor to complete hydration of the entire hydrophilic coating on the surface.

REFERENCE TO RELATED APPLICATIONS

This disclosure claims priority to, and is entitled to the benefit of,U.S. Provisional Application No. 60/493,493, filed on Aug. 8, 2003, forall subject matter commonly disclosed therein.

BACKGROUND

Intermittent catheterization is a good option for many users who sufferfrom various abnormalities of the urinary system. A common situation iswhere single use, individually packaged, sterile catheters are used. Animportant criterion for any single use product is the cost of theproduct, i.e., a less expensive product is desired and valued.

It is also quite common for catheters to be provided with a surfacetreatment using a lubricant to reduce friction in order to allow foreasier and less traumatic insertion. Currently, there are two majorcategories of catheters having lubricated surfaces, i.e., gel coatedcatheters and hydrophilic coated catheters.

The gel coated catheters are made easier to insert by application to thecatheter surface of a water-based gel that can be applied by the user,or more conveniently, it can be supplied with the packaged catheter.Typically, a system is provided with the packaged catheter to apply thegel to the catheter surface. This system may be one where the gel is putonto the catheter surface just before or during the packaging operationor one where the gel is applied to the surface as the catheter is beinginserted by the user.

In a hydrophilic coated catheter, the catheter is provided with a thinhydrophilic coating which is adhered to the outer surface of thecatheter. When this coating is activated by swelling in contact with ahydrating liquid such as water, it becomes an extremely low coefficientof friction surface. The most common form of this product is where asterile, individually packaged single use catheter is provided in a drystate or condition. The user opens the package, pours water into thepackage, waits 30 seconds, and then removes the catheter from thepackage, now ready for insertion.

A more recently introduced version of the hydrophilic coated catheter iswhere the catheter is provided in a package that already contains enoughloose liquid water to cause it to be immersed. For this product, theuser simply opens the package and removes the catheter ready forinsertion without the need to add water and wait 30 seconds. Other newproducts provide the amount of liquid water necessary for immersion ofthe catheter in a separate compartment of the package. With theseproducts, one must open the separate compartment of the package allowingthe liquid immersion water to enter the catheter-containing chamber fordirect contact with the hydrophilic coated surface. Depending on theproduct, and on the amount of water in the separate chamber, the usermay be asked to manipulate the package to bathe the catheter surface inthe hydrating liquid in order to activate the hydrophilic coating on thecatheter surface. The catheter is then removed from the package readyfor insertion by the user.

In all of these existing products, the catheter depends upon directcontact of the liquid swelling medium (e.g., liquid water) with theentirety of the hydrophilic coated catheter surface. Moreover, all ofthese existing products achieve this direct liquid water contact byproviding a package for the catheter that permits liquid water to flowfreely within the cavity of the package, and permits unobstructed accessto the catheter surface. Because of the free flow of loose liquid waterwithin the package and unobstructed access to the catheter surface, itis easy to ensure direct contact of the liquid swelling medium with theentire surface of the catheter that has been treated with thehydrophilic coating.

A disadvantage of the hydrophilic coated catheters described above isthat the immersion liquid has a tendency to spill from the package asthe user handles the catheter and tries to remove it for subsequentinsertion. Another disadvantage of the hydrophilic coated cathetersdescribed above is that the catheter has an extremely slippery surfacewhich makes it quite difficult for the user to handle during insertion.

For catheters that are removed from the package and then inserted, thereis another disadvantage in that the handling of the catheter by the userwill introduce microorganisms onto the surface of the catheter which cancause infectious problems after being introduced into the body duringcatheter insertion. To address this issue, manufacturers have devisedsystems whereby the catheter can be inserted by the user without firstremoving the catheter from the package, thus requiring the user to touchonly the package, and not the catheter surface. These systems tend towork well for gel coated catheters, and they have the additionaladvantage that the user does not get gel on his or her hands as thecatheter is being inserted. Another version of the gel lubricatedcatheter utilizes a sleeve around the catheter which is attached to agel reservoir at the insertion end of the catheter whereby the gelreservoir and sleeve come out of the package attached to the catheterwhich is inserted by advancing it through the gel reservoir. In thistype of product, the sleeve fits the catheter diameter very loosely,thereby allowing the catheter and the integral funnel which is typicallyprovided on the distal end of the catheter to slip past the sleevesurface as the catheter is advanced by the user during insertion.

For hydrophilic coated catheters, there has also been consideration ofdelivery of the catheter without first removing it from the package, buta serious problem for this type of approach is the tendency of theimmersion liquid to spill. Hydrophilic coated catheters with sleeves ofany kind have generally not been available, because the presence of thesleeve interferes with the flow of liquid water to the catheter surfacethat is required for activation by direct liquid contact. Some designsare described in the patent literature where the hydrating liquid isinside of a hose member that can be used as a no touch delivery vehicle(See, for example, United States Publication No. 2003/0018322 A1,published Jan. 23, 2003). These described hose members are stiff,though, and require special concertina folds to allow for advancement ofthe catheter, and special gripping sections to allow for gripping of thecatheter.

In some of the published patent art, for example, U.S. Pat. No.6,059,107, there is discussion of keeping low the amount of water placedin the package with the catheter. They propose to do this, however, bysimultaneously providing a narrow cavity around the catheter tubethereby using the design of the cavity to accomplish a reduction in theamount of water. In this way, the catheter remains substantiallyimmersed in and subject to direct liquid water contact while containedin the package.

In one commercial product, the cavity is not completely filled withwater, and so recommendation is made to the user to tilt or otherwisemanipulate the package prior to use, to ensure direct liquid watercontact with the catheter in order to fully activate the hydrophilicsurface coating. Similarly, some commercial products with a liquidreservoir that is to be ruptured prior to use do not have enough liquidwater to fill the package cavity that holds the catheter. The user isinstructed to tilt the package multiple times to cause liquid water tomove over the catheter to activate the hydrophilic surface coating bydirect liquid water contact. As mentioned above, the liquid water in thepackage cavity presents a spill hazard for the user when the package isopened to use the catheter. As will be appreciated, the spill hazard isgreater for hydrophilic catheters that more completely fill the packagecavity with liquid water, whereas more patient manipulation is requiredfor hydrophilic catheters that fill the cavity less completely withliquid water.

There is a tradeoff, then, between undesirable alternatives withexisting hydrophilic catheter products. On the one hand, the packagecavity is provided with a quantity of liquid water designed to keep thecatheter substantially immersed, but there is a significant spillhazard. On the other hand, when there is less liquid water relative tothe overall package cavity volume, the user must manipulate the packageprior to use to ensure activation of the catheter coating. The presentinvention avoids this tradeoff by eliminating any spill hazard whilerequiring no user manipulation.

SUMMARY OF THE INVENTION

The hydrophilic catheter of the present invention is vapor hydrated witha vapor swelling medium such as water vapor within the catheter packagein such a manner that it is ready for use when it reaches the user withlittle or no possibility of liquid spillage. It results in a sterilecatheter package that does not require the addition of an immersionliquid but, rather, already has the hydrophilic surface coating of thecatheter activated by reason of vapor hydration. The catheter packagemay contain a liquid sequestering element such as fabric or foam sizedto contain an amount of liquid that can produce sufficient vapor to formand maintain a vapor hydration atmosphere within the package cavity. Thefabric or foam liquid sequestering element reliably holds liquid in itsinterstices to prevent loose liquid from presenting a spill hazard whilepermitting vapor to be formed and escape into the package cavity. Thecatheter package of the invention may also contain a thin, flexiblesleeve of polymeric film fitting about the catheter tube. The flexiblesleeve serves to make the very lubricious vapor hydrated catheter easierfor the user to handle while also permitting sterile insertion into thebody. This is due to the outer, handling portion of the flexible sleeveof the catheter being much less slippery than the outer surface of thecatheter having the vapor hydrated hydrophilic surface coating. Thesleeve can be made to closely fit the outer surface of the cathetertube, which will reduce the amount of material used for the sleeve andso lower its cost. A close fitting sleeve will also prevent or at leastseverely limit the extent of lateral movement of the catheter within thesleeve. The sleeve can also be made of a material that permits watervapor, but not liquid water, to penetrate, and this will speed theprocess of vapor activation of the coating.

In those embodiments having a sleeve within the package, the relativelysmall quantity of liquid introduced into the package during manufactureis located externally of the sleeve. Thus, the hydrophilic surfacecoating of the catheter tube is hydrated following manufacture, afterthe package is sealed, by vapor generated within the package during anextended and predetermined period of incubation or aging prior tocatheter use. Accordingly, the catheter of the invention is provided ina cost effective, easy to manufacture manner that overcomes the problemsheretofore encountered in providing a hydrophilic coated catheter thatis ready for use. When very flexible, narrow sleeves are used, there isa further advantage in that the user can fully advance the catheterwithout the need for releasing and “resetting” the sleeve.

In particular, unlike the wide sleeves of limited flexibility that havebeen used on gel catheters, the very flexible, narrow sleeve on thehydrophilic catheter of the present invention can easily be moved fromthe insertion end toward the funnel end as the catheter tube is advancedinto the urethra in a no-touch sure grip fashion because of the highlylubricious water vapor hydrated hydrophilic coating and the collapsiblenature of the sleeve.

DRAWINGS

FIG. 1 is a top plan view, partially broken away, of a vapor hydratedpackaged hydrophilic catheter assembly according to the presentinvention;

FIG. 1 a is aside elevational view, partially in section, of thehydrophilic coated catheter assembly of FIG. 1 with the sleeve crumpledagainst the funnel;

FIG. 2 is a side elevational view, partially in section, of anotherembodiment of hydrophilic catheter assembly according to the presentinvention;

FIG. 3 a is a top plan view, partially broken away, of a basic form ofvapor hydrated packaged hydrophilic catheter assembly without a sleeve;

FIG. 3 b is a top plan view, partially broken away, of a basic form ofvapor hydrated packaged hydrophilic catheter assembly with a sleeve;

FIG. 3 c is a top plan view, partially broken away, of a vapor hydratedpackaged hydrophilic catheter assembly with a sleeve and introducer tip;

FIG. 4 is a top plan view, partially broken away, of a vapor hydratedpackaged hydrophilic catheter assembly having a vapor donatingliquid-containing vapor permeable, liquid impermeable pouch;

FIG. 5 is a top plan view of yet another embodiment of a vapor hydratedpackaged hydrophilic catheter assembly having a catheter insertion port;

FIG. 5 a is a cross-sectional view taken along the line 5 a-5 a of FIG.5 illustrating the liquid sequestering material within the package;

FIG. 6 is a top plan view of still another embodiment incorporating aurine collection bag in a vapor hydrated packaged hydrophilic catheterassembly;

FIG. 7 is a side elevational view, partially in section, of yet anotherhydrophilic coated intermittent catheter assembly similar to that ofFIG. 1;

FIG. 8 is a top plan view similar to FIG. 5 of an embodiment of ahydrophilic catheter assembly without a sleeve and catheter insertionport; and

FIG. 8 a is a cross-sectional view taken along the line 8 a-8 a of FIG.8 illustrating the liquid sequestering material within the package.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, the present invention comprises a hydrophiliccatheter assembly 10 that is adapted for vapor hydration within thecatheter package 12 so it is ready for use when it reaches the end user.The catheter package 12 is liquid and gas impermeable and may be formedof an aluminum foil. The catheter assembly 10 within the package 12includes a catheter tube 14 having an outer surface with a hydrophiliccoating on at least a portion thereof, an optional soft, rubberyintroducer tip 16 adjacent an end 14 a of the tube intended forpre-insertion into the urethral opening before advancement of thecatheter tube, and drainage eyes 18 near the proximal insertion end 14 aof the tube for draining the bladder. The catheter assembly 10 may alsoinclude a thin, flexible, collapsible sleeve 20 preferably formed of apolymeric film that is vapor permeable (although it may be liquidimpermeable) and through which the hydrophilic coating can be vaporhydrated. A connector 22 in the form of a tapered funnel is located atthe distal end of the catheter tube for connection by the user to aflexible drain tube leading to a urine collection device (not shown).

During manufacture, the catheter tube 14 is attached to the funnel 22and it receives a hydrophilic coating on its outer surface. The flexiblehydrogel sleeve 20 is then placed over the tube 14 and the introducertip 16, if needed, is added to complete the catheter assembly 10. Thesleeve is attached either to the funnel or to the introducer tip orport, or to both. The catheter assembly 10 is then inserted into acavity 12 a formed within and defined by the package 12, together with asmall pre-determined amount of a vapor donating liquid such as water asat 24, after which the package is sealed. The presence of water withinthe sealed gas impermeable package 12 causes water vapor to be formedover a determinable period of time. The flexible sleeve 20, preferablyof a thin, flexible hydrogel material, has a high water vaportransmission rate. Thus, the flexible hydrogel sleeve 20 permits thewater vapor created by the evaporating liquid located externally of thesleeve to enter and hydrate the hydrophilic coating on the outer surfaceof the tube 14.

The hydrophilic coating on the outer surface of the tube 14 thereforebecomes hydrated by reason of exposure to the water vapor. Thisactivates the hydrophilic coating to create a highly lubriciouscondition on the outer surface of the tube 14 which places the catheterassembly 10 in a ready-to-use condition. The catheter assembly is agedfor a predetermined period after completion of the packaging process, toensure complete activation of the coating. The catheter assembly canthen be removed by the user from the package 12 and used immediately.Moreover, this can all be accomplished without the necessity for theuser to add water and without the user encountering the prior artproblems of water spillage when the package is opened.

The sleeve 20 may be formed of any of a variety of thin, flexiblepolymeric film materials, such as polyethylene, plasticized PVC, orpolypropylene, but elastomeric film materials such as polyurethane, andparticularly elastomeric hydrogel materials, are believed particularlysuitable. One such material is a polyurethane polyethylene oxide blockcopolymer commercially available under the trademark Medifilm 435 fromMylan Labs, St. Albans, Vt., but other elastomeric hydrogel films areknown and may be used. Most desirably, the film is vapor permeable,since such vapor permeability promotes distribution of vapor within thepackage and facilitates vapor hydration of the catheter's hydrophiliccoating. It is also preferred that the film be impermeable to liquidwater, to ensure a complete barrier to microbe penetration, although aliquid permeable sleeve may in some instances be used.

The thickness of the film from which the sleeve is fainted may varyconsiderably depending on factors such as stretchability and flexibilityof the material selected but, in general, the thickness will fall withinthe range of about 10 to 150 microns, preferably about 13 to 50 microns.Similarly, the aging or incubating time required to achieve full vaporhydration depends on a number of variables such as the moisture vaportransmission rate (MTVR) of the material of the sleeve, the size of thepackage as a whole, the diameter of the sleeve in relation to othercomponents such as the catheter tube, and the ambient temperatures andpressures involved. In any event, the interval between packaging and useis both substantial and predetermined for any given product to ensurethat the vapor donating liquid within the package has vaporizedsufficiently to produce a condition of 100% humidity—with complete vaporhydration of the hydrophilic coating—by the time the catheter isrequired for use. At such time, the amount of vapor donating liquid leftwithin the package should be so slight as to constitute enough tomaintain a condition of 100% humidity without presenting any risk ofspillage when the catheter is removed from the package at the time ofuse. Recognizing the variables given above, the interval betweenpackaging and use will generally be on the order of 1 to 45 days ormore.

As an alternative to aluminum foil, which is a very good water vaporbarrier, other packaging materials may be chosen for otherconsiderations, such as thermoformability or cost. It is to beunderstood that the term “gas impermeable” in regard to the package is arelative term. The package must be enough of a barrier to moisture vaporto maintain a 100% relative humidity condition inside the package toensure continuous hydration of the hydrophilic coated catheter for thedesired shelf life of the packaged catheter assembly. The barrierproperties required for this goal will depend on the length of thedesired shelf life (typically between six months and five years), theamount of vapor donating liquid placed in the package prior to sealingthe package, and the conditions under which the product is stored.

To use the catheter assembly 10, the user may simply remove it from thepackage 12 by gripping the sleeve 20 and then gently insert theintroducer tip 16 into the urethral opening. Preferably, the catheterassembly 10 is gripped by the sleeve 20 in one hand for advancement ofthe formed tip 14 a of the tube 14 into and through the introducer tip16, such introducer tip having a plurality of crossed slits 16 adefining a circumferential array of flaps 16 b that flex outwardly toform an opening for allowing passage of the tube 14 therethrough.Thereafter, the tube is gently advanced by using the other hand to gripthe tube between wall portions of the sleeve and urge the tube forwardlyor proximally. As the tube 14 advances through the urethral opening intothe body, the sleeve 20 will crumple adjacent the funnel 22 of thecatheter assembly 10 as shown in FIG. 1 a.

Referring to FIG. 2, a catheter assembly 110 is disclosed which is quitesimilar to the catheter assembly 10 described above. A liquid and gasimpermeable package or container, which may be similar to the package12, encloses the assembly 110 but is omitted in FIG. 2 for clarity ofillustration. As in FIG. 1, a small predetermined amount of vapordonating liquid such as water is introduced into the package, externalto the catheter assembly, for vapor hydration of the hydrophilic coatingduring the interval following sealing of the package and prior tocatheter use.

The catheter assembly 110 comprises a tube 114 having an outer surface,drainage eyes 118 for draining the bladder, and a thin, flexible sleeve120, preferably of an elastomeric hydrogel film, through which the tube114 can be vapor hydrated in accordance with the invention, and it mayalso include a funnel 122 for connection to a urine collection device.However, the principal difference in the catheter assembly 110 is theabsence of the introducer tip 16 that is present in the catheterassembly 10.

In use of the catheter assembly 110 of FIG. 2, the sleeve 120 is pulledback slightly to expose the formed tip 114 a of the tube 114. The formedtip 114 a is then inserted into the urethral opening, and the tube 114is advanced into the body by gripping it through the sleeve 120. Asbefore, the sleeve 120 crumples adjacent the funnel 122 of the catheterassembly 110 similar to what is shown in FIG. 1 a.

Referring to FIG. 3 a, the catheter assembly 310 is a simple, lessexpensive arrangement similar to the catheter assembly 10 describedabove. The catheter assembly 310 comprises a tube 314 having an outersurface, a formed tip 314 a, and drainage eyes 318 for draining thebladder, and it may also include a funnel 322 for connection to a urinecollection device if required by the user. However, there are severaldifferences that are noteworthy in relation to the catheter assembly 10described above.

First, it will be noted that a predetermined amount of vapor donatingliquid such as water can be provided within a fabric or open-cellpolymeric foam liquid sequestering element 330 that may either beintegrally associated with one of the walls such as 312 a and 312 b of agas impermeable package 312 or may be loose within the package 312surrounding the catheter assembly 310. The fabric or foam liquidsequestering element 330 is sized to contain an amount of water thatproduces sufficient water vapor to form and maintain a 100% relativehumidity atmosphere within the package 312. Since water vapor escapingfrom the fabric or open-cell polymeric foam liquid sequestering elements330 is sufficient to form and maintain such an atmosphere within thepackage 312, the hydrophilic coating on the outer surface of the tube314 of the catheter assembly 310 is and remains fully vapor hydrated sothe catheter is ready for use.

In addition to the liquid sequestering element 330, the catheterassembly 310 will be seen to comprise a simple hydrophilic coatedcatheter assembly without any sleeve or introducer tip. The catheterassembly 310 is placed in the gas impermeable package 312 with a vapordonating liquid such as liquid water, and the material from which theliquid sequestering element 330 is formed is selected to have a highcapillary draw to absorb all of the available liquid water to preventany loose liquid water from being able to flow within the sealed cavityof the package 312. The liquid sequestering element is used not only tofully absorb the liquid water but also to give off water vapor after thecavity in the package 312 has been sealed to achieve vapor hydration.

Depending upon various parameters including the temperature of theliquid water placed in the package 312 and the characteristics of thehydrophilic material selected to coat the outer surface of the tube 314,vapor hydration will occur over an extended, but determinable, timeperiod after the package has been sealed. The distribution of thepackaged catheter assembly can therefore be delayed for a determinableperiod of time after completion of manufacture to ensure formation of a100% relative humidity atmosphere within the package 312 and full andcomplete vapor hydration of the catheter. As for the liquid sequesteringelement 330, the material may, e.g., be a microfiber meltblown fabric,e.g., PF23100PBT manufactured by Hollingsworth & Vose Company which hasbeen surface treated to make it liquid water wettable.

By forming the liquid sequestering element 330 of a material having ahigh capillary draw, the liquid water is contained in the package andnot able to spill when the package is opened. This water serves as adonor to form water vapor that comprises the vapor swelling liquid forvapor hydration of the hydrophilic coating on the outer surface of thetube 314 of catheter assembly 310 after the gas impermeable package 312holding the liquid sequestering element 330, the catheter, and the waterhas been sealed following manufacture. The fabric or foam material ofthe liquid sequestering element 330 becomes at least partially saturatedwith available liquid water for this purpose. Then, after the cavity inthe gas impermeable package 312 has been sealed, the liquid waterconfined within the fabric or foam material is slowly released as watervapor until the package reaches an equilibrium state in which the airwithin the sealed package cavity is fully saturated with water vapor,and the water vapor is available for uptake by the hydrophilic coatingon the outer surface of the tube 314 which causes the hydrophiliccoating to swell so the catheter is ready for use.

Vapor hydration proceeds faster if the source of vapor is closer to theouter surface of the tube of the catheter having the hydrophilic coatingthereon. It will be appreciated by referring to the embodiment of FIG. 3a as well as all of the other embodiments using a liquid sequesteringelement (with the exception of the embodiment of FIG. 4) that the liquidsequestering element has been made substantially coextensive and inalignment with the length of the catheter to take advantage of this.Otherwise, vapor hydration will still occur in accordance with theinvention although the time for complete hydration will be longer. Ifthe liquid sequestering element is confined completely to one end of thepackage, the vapor hydration time may be considerably longer, and maybecome so long as to be undesirable, depending on the nature of thehydrophilic coating.

With regard to commercially available hydrophilic coatings, the time forthem to become fully hydrated varies significantly. Thus, in actualtesting it has been learned that one such coating was fully lubriciousafter two days whereas another, under the same conditions, was still notfully lubricious after two weeks. In one case, the coating was not fullylubricious until approximately six weeks after the package was sealed.

Despite the wide diversity in time for reaching full lubricity, and thecommercial desirability of reaching full lubricity in a relatively shortperiod of time after manufacture, the advantages of the invention can beenjoyed with any hydrophilic coating.

Referring to FIG. 3 b, the catheter assembly 310′ is an arrangementquite similar to the catheter assembly 110 described above, and it isdisposed within a sealed cavity 312 a′ of a liquid and gas impermeablepackage 312′ defined by the walls 312 b′ and 312 c′. It will be seenthat the catheter assembly 310′ again includes a tube 314′ having anouter surface and drainage eyes 318′ for draining the bladder and,again, the catheter assembly 310′ may include a funnel 322′ which issuitable for connection to a urine collection device. Also, like thecatheter assembly 110, the catheter assembly 310′ includes a thin,flexible sleeve 320′ preferably of an elastomeric hydrogel film throughwhich the tube 314′ can be vapor hydrated.

As with the embodiment of FIG. 3 a, a predetermined amount of vapordonating liquid such as water can be provided within a fabric oropen-cell polymeric foam liquid sequestering element 330′ that mayeither be integrally associated with one of the walls such as 312 a′ and312 b′ of a gas impermeable package 312′ or may be loose within thepackage 312′ surrounding the catheter assembly 310′. Like the liquidsequestering element 330, the fabric or foam liquid sequestering element330′ is sized to contain an amount of water that produces sufficientwater vapor to form and maintain a 100% relative humidity atmospherewithin the package 312′. Since water vapor escaping from the fabric oropen-cell polymeric foam liquid sequestering element 330′ is sufficientto form and maintain such an atmosphere within the package 312, thehydrophilic coating on the outer surface of the tube 314 of the catheterassembly 310 is and remains fully vapor hydrated so the catheter isready for use.

Unlike the embodiment of FIG. 3 a, the thin, flexible sleeve 320′ isinterposed between the liquid sequestering element 330′ and the tube314′ of the catheter assembly 310′. It is generally known that highlyflexible sleeves such as 320′ which are formed of an elastomerichydrogel film are liquid water impermeable which has meant they havegenerally been dismissed for use with hydrophilic coated catheters whichhave heretofore been hydrated by direct liquid contact.

In other words, it is water vapor hydration that makes it possible toreliably use a sleeve 320′ on the catheter assembly 310′. Thus, watervapor hydration permits activation of the hydrophilic coating on theouter surface of the tube 314′ of the catheter assembly 310′ to ensureit is ready-to-use, unlike liquid water that could not reliably reachthe coating. Since sleeves such as 320′ prevent direct liquid contactwith the hydrophilic coating, they have not previously been viewed assuitable for use with ready-to-use hydrophilic coated catheters.

In use of the catheter assembly 310′ of FIG. 3 b, the sleeve 320′ ispulled back slightly to expose the formed tip 314 a′ of the tube 314′.The formed tip 314 a′ is then inserted into the urethral opening and thetube 314′ is advanced into the body by gripping it through the sleeve320′. As before, the sleeve 320′ crumples adjacent the funnel 322′ ofthe catheter assembly 310′ similar to what is shown in FIG. 1 a.

Referring to FIG. 3 c, a catheter assembly 310″ is disclosed which isalso quite similar to the catheter assembly 10′ described above. Thecatheter assembly 310″ will be seen to comprise a tube 314″ having anouter surface with a hydrophilic coating, a formed tip 314 a″, anintroducer tip 316″, drainage eyes 318″ for draining the bladder, and aflexible sleeve 320″, and it also will be seen to include a funnel 322″for connection to a urine collection device if desired. However, theprincipal difference in the catheter assembly 310″ will be seen to bethe use of a liquid sequestering element 330″ within the sealed cavity312 a″ of a liquid and gas impermeable package 312″ defined by walls 312b″ and 312 c″.

In the embodiment of FIG. 1, the liquid water is placed loosely withinthe cavity of the package 12 to create the water vapor hydratingatmosphere that will cause the hydrophilic coating on the outer surfaceof the tube 14 of the catheter assembly 10 to be activated. The sleeve20 is impermeable to the loose liquid water within the sealed cavity ofthe package 12 but is preferably water vapor permeable. Thus, the looseliquid water forms a water vapor atmosphere within the sealed cavity ofthe package 12 which reaches an equilibrium condition and activates thehydrophilic coating on the outer surface of the tube 14.

In contrast, the embodiment of FIG. 3 c achieves water vapor hydrationof the hydrophilic coating on the outer surface of the tube 314″ of thecatheter assembly 310″ in the manner described in connection with FIG. 3b through water vapor which is given up by the liquid water in theliquid sequestering element 330″ rather than from water vapor formedfrom loose water as in FIG. 1.

Referring to FIG. 4, another aspect of the invention is disclosedwherein the vapor donating liquid such as water is provided within awater vapor permeable but liquid impermeable pouch 428 that is placedinside a gas and liquid impermeable package 412. The catheter assembly410 shown in the package 412 has the hydrophilic surface coating on thetube 414 completely hydrated by water vapor from the vapor permeablepouch 428 which will be sized to contain an amount of water that canproduce sufficient water vapor to form a 100% relative humidityatmosphere within the package 412. In this manner, it is possible tocompletely activate the hydrophilic surface coating on the tube 414 withwater vapor hydration rather than direct liquid water contact, and tomaintain a 100% relative humidity atmosphere within the package for thedesired shelf life of the product.

By way of example, the water vapor permeable pouch 428 can be sized tocontain, e.g., 20 ml of water. Water can escape from the pouch in theform of water vapor that will fill the interior of the gas impermeablepackage 412 to cause the hydrophilic coating on the outer surface of thetube 414 of the catheter assembly 410 in the package to become fullyhydrated within an easy to determine and control time period followingcompletion of the packaging process.

Referring to FIGS. 5 and 5 a, still another aspect of the invention isdisclosed wherein a predetermined amount of a vapor donating liquid suchas water is provided within a fabric or open-cell polymeric foam liquidsequestering element 530 that may either be integrally associated withthe walls 512 b and 512 c of a gas impermeable package 512 (as shown) ormay be loose within a sealed cavity 512 a of the package 512 surroundingthe catheter assembly 510. The catheter assembly 510 shown in thepackage 512 is somewhat different from earlier embodiments in that itutilizes a port 532 which, in the illustrated embodiment, takes the formof an annular guide housing located at the end opposite the funnel 522.The port has an axial passage for sliding advancement of the cathetertube 514 therethrough. However, it will be understood and appreciatedthat any of the various catheter assembly embodiments could be packagedin a package such as 512 that has a fabric or foam liquid sequesteringelement 530 contained therein. The fabric or foam liquid sequesteringelement 530 is sized to contain an amount of water that can producesufficient water vapor to form and maintain a 100% relative humidityatmosphere within the package 512. Sealingly secured to the outersurface of the port 532 is a wide, thin-walled sleeve 534 extendingdistally therefrom to cover the catheter tube 514 substantially alongits entire length into the region of the funnel 522. This wide sleeveallows the funnel to enter the sleeve as the catheter is being advancedinto the body, when the catheter is being used. Water vapor escapingfrom the fabric or foam liquid sequestering elements 530 can fullyhydrate the hydrophilic coating on the outer surface of the tube 514 ofthe catheter assembly 510 in order to be ready for use.

More specifically, the water vapor can fully hydrate the hydrophiliccoating by passing through the sleeve 534 if it is formed of a materialthat has a sufficiently high water vapor transmission characteristicand/or by passing through the open end 534 a of the sleeve 534 into thespace between the sleeve and the catheter tube 514 whether the sleeve isvapor permeable or not.

Still referring to FIGS. 5 and 5 a, it will be seen that there is aperipheral seal 512 d entirely surrounding the catheter assembly 510within the sealed cavity of the gas impermeable package 512. The port532 makes it possible to open the package 512 at the end nearest theport 532, remove the catheter from the package, and use the port 532 tointroduce the catheter tube 514 into the urethral opening. Thereafter,the user may continue the process of further inserting the tube 514 intothe body in a sterile manner by gripping it through the sleeve 534 andfeeding it through the port 532 in a manner previously disclosed.

Referring to FIG. 6, yet another aspect of the invention is disclosedwherein a predetermined volume of water is provided within a fabric orfoam liquid sequestering element 630 in the form of a thin, elongatedstrip extending for the entire length of the catheter. The liquidsequestering element 630 may be integral with one or both of the wallssuch as 613 a of a urine collection bag 613 that can be contained withina gas impermeable package of the types described above. The catheterassembly 610 shown in the bag 613 is similar to the embodiment of FIG. 1in that it utilizes an introducer tip 616 at the end opposite the funnel622 through which the catheter tube 614 can be advanced as it isintroduced into the body. The fabric or foam liquid sequesteringelement(s) 630 may be formed of a non-sticking material such as abicomponent fiber through air bonded fabric that has been hot calenderedon one side to form a liquid permeable skin, or may be covered alongtheir inner surfaces with a very thin film (preferably an elastomerichydrogel film) to prevent sticking of the liquid sequestering elementson the surface of the catheter tube 614. The liquid sequesteringelement(s) 630 are sized to contain an amount of water that can producesufficient water vapor to form and maintain a 100% relative humidityatmosphere within the package for the urine collection bag 613. In thismanner, the water vapor escapes from the fabric or foam liquidsequestering element(s) 630 through the thin hydrogel elastomer film sothat over a predetermined time interval it can fully hydrate thehydrophilic coating on the outer surface of the tube 614 of the catheterassembly 610 in order to be ready for use.

While not shown in the drawings, it will be appreciated that embodimentsof the fabric or foam liquid sequestering element where the liquidsequestering element is not integrally associated with the walls of thebag 613 are also possible.

A feature of the embodiments that utilize a vapor donating liquid suchas water in a fabric or foam liquid sequestering element is that thewater is not designed to be capable of hydrating the catheter by directcontact with the catheter surface. This is because the liquidsequestering element will hold the liquid water in its interstices, thuspreventing loose liquid water from presenting a spill hazard. The liquidsequestering element materials are preferably fabrics or foams that arenot easily compressed, which would tend to expel water from theinterstices. They should be fabrics or foams that are resistant tocompression so they will reliably contain the water in theirinterstices. In preferred embodiments, the amount of water in the fabricor foam liquid sequestering element will also be not of sufficientvolume to immerse the catheter, even if the water were able to escapefrom the liquid sequestering element. However, the fabric or foam liquidsequestering element makes it possible to use a larger volume of waterin certain applications such as where it might be desired to form thepackaging of a more permeable material.

Because of the foam or fabric liquid sequestering element, the largervolume of water can be used without appreciably increasing the spillhazard even if the package is opened soon after manufacturing.

As time passes, the amount of water in the more permeable package willgradually decrease as water vapor escapes from the package which willfurther reduce or eliminate any possible spill hazard.

Thus, it will be appreciated that the use of liquid sequesteringelements allows for inclusion of larger amounts of water in the packageat the time of sealing, permitting the use of less impermeable packagingmaterials that may be desirable for the reasons discussed above.Embodiments that utilize a liquid sequestering element can have largeramounts of water included in the package without having any significantloose water in the package at the time of removal of the catheter fromthe package that would otherwise present a spill hazard at that time.

Referring to FIG. 7, a catheter assembly 710 is disclosed which is alsoquite similar to the catheter assembly 10 described above. The catheterassembly 710 will be seen to comprise a tube 714 having an outer surfacewith a hydrophilic coating, an introducer tip 716, drainage eyes 718 fordraining the bladder, and a flexible sleeve 720 in accordance with theinvention, and it also will be seen to include a funnel 722 forconnection to a urine collection device if desired. However, theprincipal difference in the catheter assembly 710 is the use of a widersleeve 720 secured to the introducer tip.

To use the catheter assembly 710, the user may simply remove it from itspackage (not shown) by gripping the wide sleeve 720 and gently insertingthe introducer tip 716 into the urethral opening. The catheter assembly710 is gripped by the wide sleeve 720 in one hand for insertion of theformed tip 714 a of the tube 714 into the urethra, and the tube 714 isgently pushed into the body using the wide sleeve 720 to advance thetube through the introducer tip 716. As the tube 714 advances throughthe urethral opening into the body, the wide sleeve 720 is of asufficient size to receive the funnel 722 which may continue to advancethrough the sleeve until it reaches the introducer tip 716. This is anarrangement one could use when a sleeve is made from an inexpensivethough relatively stiff material, like polyethylene.

Although not shown in a package, it will be appreciated that thecatheter assembly 710 can be provided in a package such as any of thosedescribed above in order for vapor hydration to ensure completeactivation of the hydrophilic coating on the outer surface of the tube714 as a result of creation of a 100% relative humidity atmospherewithin the package.

Referring to FIGS. 8 and 8 a, an embodiment similar to FIGS. 5 and 5 ais disclosed wherein a predetermined amount of a vapor donating liquidsuch as water is provided within a fabric or open-cell polymeric foamliquid sequestering element 830 that may either be integrally associatedwith the walls 812 b and 812 c of a gas impermeable package 812 (asshown) or may be loose within a sealed cavity 812 a of the package 812surrounding the catheter assembly 810. As mentioned before, it will beunderstood and appreciated that any of the various catheter assemblyembodiments could be packaged in a package such as 812 that has a fabricor foam liquid sequestering element 830 contained therein. The fabric orfoam liquid sequestering element 830 is sized to contain an amount ofwater that can produce sufficient water vapor to form and maintain a100% relative humidity atmosphere within the package 812. Water vaporescaping from the fabric or foam liquid sequestering elements 830 canfully hydrate the hydrophilic coating on the outer surface of the tube814 of the catheter assembly 810 in order to be ready for use.

In this embodiment, the fabric or foam liquid sequestering element 830will preferably have a thin vapor permeable film 830 a on the surfacesfacing the catheter assembly 810 to prevent the fabric or foam fromsticking to the surfaces of the catheter assembly. More specifically,the water vapor can pass through the vapor permeable film which ispreferably formed of a hydrogel material to thereby fully hydrate thehydrophilic coating by vapor contact with the surface of the cathetertube 814.

While not specifically shown in other embodiments, the liquidsequestering elements in each of the embodiments utilizing this featurecan have a film covering over the fabric or open-cell polymeric foammaterial to prevent the material from sticking to the coating on thecatheter tube. Alternatively, the film can be replaced with a polymericnetting or a perforated plastic film. Another way to achieve the samegoal is to use a fabric for the material of the liquid sequesteringelement that is thermally bonded through the use of binder fiber (i.e.,through air bonded fabrics) which develops a liquid permeable skinduring manufacture to provide a non-stick surface.

In another respect, the catheter assembly of the invention can besupplied to the user either sterile or non-sterile depending uponwhether it is subjected to a known sterilization procedure.

With the present invention, there are at least two significantadvancements that have been achieved for the first time by providing ahydrophilic coated catheter which is ready-for-use, highly lubricious,easy to handle, and cost effective.

The first advancement resides in providing a hydrophilic coated catheterthat is fully hydrated and ready-for-use without need for an immersionfluid that could spill when the package is opened. It has been found,surprisingly, that this can be achieved by simply adding to the gasimpermeable catheter package a small amount of water which is less thanwhat would be required to immerse the catheter, and less than what couldcause a spilling problem. The commercial distribution of the packagedcatheter assembly is then managed in such a manner that the product willnot be made available to the user prior to an adequate aging periodwhich is determined to be sufficient i) to create a 100% relativehumidity atmosphere within the package, and ii) to ensure vaporhydration of the hydrophilic coating on the outer surface of thecatheter tube. By using very little water and managing commercialdistribution in this manner, it is possible to provide a fully hydrated,ready-to-use hydrophilic coated catheter that will not be capable ofliquid spillage when the catheter is removed from the package for use.

The second advancement resides in providing a hydrophilic coatedcatheter that utilizes a simple sleeve that is inexpensive tomanufacture but easy to use. It has been found that simple sleeves suchas those that are typical of ones that have been used on gel coatedcatheter products in the past show some disadvantages when they are usedfor hydrophilic coated intermittent catheters. However, thosedisadvantages are overcome by using vapor hydration to activate thehydrophilic coating in accordance with the present invention.

What has been achieved with the present invention is the advancement ofproviding a flexible sleeve with a fully vapor hydrated hydrophiliccoated catheter that has no risk of liquid spillage by reason ofprepackaging an assembly comprised of the catheter and sleeve with asmall amount of vapor donating liquid following which the commercialdistribution of the product is managed in a way that ensures the productwill not be available to the user prior to complete hydration as theresult of an adequate aging period.

The required aging period depends on whether a sleeve is used and, ifso, the materials chosen for the sleeve. Inexpensive materials such aspolyethylene can be used even in very thin, flexible sleeves providedthe aging period is adequate. However, it has been found that the agingperiod which is required can be reduced by choosing sleeve materialsthat are more permeable to water vapor than polyethylene. For example, awater vapor permeable, but non water-swellable, elastomer film can beused which does not require as long of an aging period as doespolyethylene. Furthermore, a water swellable elastomer film which iseven more permeable to water vapor can be used as a sleeve material inorder to require an even shorter aging period. In general, the requiredaging period will be shorter for sleeve embodiments where the sleeve hashigher water vapor permeability.

As will be appreciated, using a sleeve material having a greater degreeof flexibility results in a sleeve that provides essentially nonoticeable resistance to the advancement of the catheter, even as thesleeve is bunched against the catheter funnel during insertion. This isa significant benefit to the user of the catheter and sleeve assembly.When a very flexible sleeve material is used, there is no need torelease and “reset” the sleeve during the insertion. Instead, one canfully insert the catheter without releasing one's grip on the sleeve.

Test 1 below shows that in using a wide polyethylene film sleeve with ahydrophilic coated catheter in the traditional way of adding enoughwater to the package to immerse the catheter, and waiting 30 seconds,complete hydration of the catheter is not achieved. Further, as shown inthe table for Test 1, it has been found that use of narrower sleeveshaving the more desirable characteristics noted above give even worseresults for hydration.

More flexible sleeves, which are capable of allowing the catheter to beinserted without resisting catheter advance as the sleeve accordions,are also useful. However, the table for Test 1 shows that as the sleeveis made of thinner material to provide a more flexible sleeve, one getseven worse results in regard to hydration. Thus, the use of a simplesleeve with a traditional hydrophilic coated catheter provided in thetraditional dry format has important disadvantages.

Test 2 below shows the results of aging hydrophilic coated cathetersthat have narrow, flexible sleeves, and that are packaged with varioussmall amounts of water. Amounts of water, e.g., on the order of 2 to 3ml, can be added to the package which, after aging, results in a fullyhydrated and fully lubricious catheter (a coefficient of friction of0.03 or lower is considered indicative of full lubricity). The use ofthis relatively limited amount of water means the sealed package cavitycontaining the catheter will be almost empty, and there will be littleor no loose or free liquid water remaining in the package when it islater opened for use of the catheter. Also, slightly larger amounts ofwater, e.g., 4 to 5 ml, or even higher, can be used if the cavity issufficiently large in volume, because the limited water left in thepackage at the end of aging represents such a small fraction of theoverall cavity volume that it is not a significant spill hazard. Amountsof loose water should be used that occupy less than 20% of the volume ofat least the tube-receiving portion of the catheter receiving cavity ofthe package.

In the embodiment illustrated in FIG. 1, the catheter receiving cavityis a single, large open cavity that receives the entirety of thecatheter assembly 10, including not only the catheter tube 14 but alsothe funnel 22. Preferably, the loose water should occupy less than 10%,and most preferably less than 5% of the total volume of thetube-receiving portion of the catheter receiving cavity of the package.This contrasts with the 10 ml or more of liquid normally used forimmersion of catheters, in narrow cavities that are typically filled to45-60% of their capacity, for liquid activation, thereby presenting adefinite spill hazard at the time the catheter is removed from thepackage for use.

Test 3 below shows that after two weeks of aging at room temperature,catheters with a polyethylene sleeve are not fully hydrated whereasthose with water vapor permeable elastomer film sleeves are. These watervapor permeable elastomer films have a further advantage overpolyethylene in that they have a much greater degree of flexibilitywhich is a benefit in use of the catheter assembly. However, Test 3shows that if a long enough aging period is used, full vapor hydrationcan be achieved even when a close fitting water vapor impermeable sleeve(e.g., a polyethylene sleeve) is used.

Test 4 below shows that in a given aging period, the catheter with theless permeable elastomer film sleeve (Medifilm 810) is not as fullyhydrated as the catheter with the more permeable elastomer film sleeve(Medifilm 435).

Test 5 below shows that sleeves have yet another advantage when used inconjunction with vapor hydrated hydrophilic coated catheters. Theyreduce the rate at which the hydrated catheter will dry out as it isexposed to air when the user opens the package containing the catheterwhich, in turn, increases the time that the user may take to insert thecatheter without the risk of a decrease in the lubricity of thecatheter. It has been found that this advantage remains even for sleevesof extremely high water vapor permeability. It will also be appreciatedthat the more fully the catheter is hydrated on insertion the lesschance for premature drying of the catheter within the body prior toremoval.

Test 6 below shows the results of aging low cost catheters that do nothave sleeves that are packaged with a liquid sequestering elementcontaining vapor donating water. Depending on the hydrophilic coating,it may take a relatively short time (2 days), or a relatively long time(more than 6 weeks) for the coating to become fully lubricious.

In the tables which accompany the tests described below, there arevalues set forth in some instances for the coefficient of friction. Eachcoefficient of friction measurement listed in the tables was obtained asfollows: Two catheters were prepared and aged in the same way. Eachcatheter was then cut into four or six short segments. Two shortsegments from a catheter were then placed in a fixture. A sled waspulled across the surface of both segments for one measurement. This wasrepeated in five independent trials. The average coefficient of frictionis reported in the tables.

In regard to the percent filling of the tube-receiving portion of thecatheter receiving cavity of the package with hydrating liquid, it ismeasured as follows. First, the catheter package, as received by theuser, is held in a vertical fashion with the funnel end of the catheterat the top of the package. Then, the funnel end (top) of the package isopened and peeled to the base of the funnel, where the funnel firstmeets the shaft of the catheter tube. The hydrating liquid that is inthe package is poured out and measured, without disturbing the catheterin the package. Next, water is poured into the package to fill theentirety of the tube-receiving portion of the catheter receiving cavityof the package until the water begins to spill out. Then, the water inthe tube-receiving portion of the catheter receiving cavity of thepackage is poured out and measured. This amount of water represents thevolume of the tube-receiving portion of the catheter receiving cavity ofthe package.

Once the amount of hydrating liquid or vapor donating liquid that wascontained in the package has been measured, and the amount of waterneeded to fill the tube receiving portion of the catheter receivingcavity of the package has been measured, the ratio between these twoamounts should be less than 20%, to ensure against a spill hazard forthe user.

The tests described below and the results derived from those testsdemonstrate the advantages to be derived from the present invention.

Test 1:

In this test, dry hydrophilic catheters are immersed in water for 30seconds including a sleeveless control catheter and catheters havingsleeves. Subsequently, the catheters including the control and thosewith sleeves were tested for percent hydration based on wet weightversus dry weight. Commercially available hydrophilic catheters wereused for this test, i.e., LoFric® catheters available from Astra Techand EasiCath® catheters from Coloplast. The results are as follows:

Weight Gain Weight Gain Sample Description LoFric EasiCath Control withno sleeve Assume 100% Assume 100% Catheter with 50 microns thick, 81%89% 30 mm wide Polyethylene sleeve Catheter with 50 microns thick, 51%81% 8 mm wide Polyethylene sleeve Catheter with 36 microns thick, 45%66% 8 mm wide Polyethylene sleeve Catheter with 25 microns thick, 35%58% 8 mm wide Polyethylene sleeve Catheter with 25 microns thick, 13%Sleeve stuck to 8 mm wide Medifilm 435 catheter swellable elastomersleeve

Test 2:

In this test, hydrophilic catheters are placed in Aluminum foil packageswith from 0.5 ml to 4 ml of water added to each of the packages. Thetotal volume of the packages is about 80 ml. The catheters are Ch 14catheters with a 12 mm wide sleeve of Medifilm 437. They are packagedand then aged at room temperature for three weeks. They are then removedfrom the package and tested in order to determine the coefficient offriction (COF). Commercially available hydrophilic catheters were usedfor this test, i.e., Lo Fric® catheters available from Astra Tech. Theresults are as follows:

Volume of Water Percent of Added (ml) cavity fill COF 0.5 ml 0.6% 0.041.0 ml 1.3% 0.03 2.0 ml 2.5% 0.03 3.0 ml 3.8% 0.02 4.0 ml  5% 0.02

Test 3:

In this test, hydrophilic catheters Ch12 were fitted with 8 mm widesleeves of different materials and packaged with 5 ml of water. Thecatheters were aged for either one or two weeks (Wk(s)), at either roomtemperature (RT) or at 40° C. and were tested for coefficient offriction (COF). Commercially available hydrophilic catheters were usedfor this test, i.e., Lo Fric® catheters available from Astra Tech. In aseparate experiment (results not shown), a fabric water sequesteringelement as opposed to a small amount of loose water was used. In thisarrangement, with a Ch 14 catheter with a narrow 12 mm polyethylenesleeve, we found that after 3 weeks at 40° C., the catheters were fullyactivated (COF=0.02). The results are as follows:

COF 1 COF COF COF Wk/ 2 Wks/ 1 Wk/ 2 Wks/ Sample Description RT RT 40°C. 40° C. Catheter with 50 tacky tacky 0.02 0.02 microns thick surfacesurface Polyethylene sleeve Catheter with 51 0.02 0.02 0.02 0.02 micronsthick non- swellable elastomer film (Medifilm 810) Catheter with 25 0.020.02 0.02 0.02 microns thick swellable elastomer film (Medifilm 435)

Test 4:

In this test, hydrophilic catheters were fitted with 8 mm wide sleevesof different materials and packaged with 2 ml of water. The catheterswere then aged at room temperature for 24 hours. Commercially availablehydrophilic catheters were used for this test, i.e., Lo Fric® cathetersavailable from Astra Tech. The results are as follows:

Percent Hydration (Based Upon Wet Sample Description Wt. v. Dry Wt.)Catheter with 25 microns thick swellable Assume 100% elastomer film(Medifilm 435) Catheter with 51 microns thick non- 67% swellableelastomer film (Medifilm 810)

Test 5:

In this test, hydrophilic catheters were packaged with 5 ml of water andthen aged in an oven for 48 hours at 40 C. After aging, the catheterswere removed from the package and exposed to air for a given time. Ifthe catheters had a sleeve, the sleeve was left on for the exposuretime, then pushed back to test for coefficient of friction. Commerciallyavailable hydrophilic catheters were used for this test, i.e., Lo Fric®catheters available from Astra Tech. The results are as follows:

COF/2 COF/5 COF/10 Sample Description Min. Min. Min. Catheter with nosleeve 0.02 0.04 0.09 Catheter with Medifilm 435 Sleeve 0.02 0.02 0.02Catheter with Medifilm 810 Sleeve 0.02 0.02 0.02

Test 6:

In this test a fabric liquid sequestering element was used in vaporhydration of catheters. Two different types of commercially availableCh14 hydrophilic coated catheters were used. In some cases thesecatheters were fitted with close fitting sleeves of Medifilm 437, avapor permeable thin elastomer film. Two different test systems wereused. In the “Test Tube” system, catheters were placed in a sealed testtube, where they were separated from the liquid sequestering fabric by ametal screen. In this system it is impossible for the water in thefabric to contact the catheter. The second system, “Package” is acommercial type system where the catheter and the water sequesteringfabric are in a sealed foil package. The results are as follows:

2 days 1 week 3 weeks 6 weeks Catheter Sleeve/ Package/ aged aged agedaged used No Sleeve Test Tube COF COF COF COF LoFric No Sleeve Test Tube0.02 0.02 0.02 ND EasiCath No Sleeve Test Tube 0.07 0.06 0.04 NDEasiCath No Sleeve Package ND ND 0.04 0.04 EasiCath Sleeve Package ND ND0.04 0.03 (The abbreviation ND in this table indicates the test was NotDone for the stated conditions)

In the foregoing description, the catheter embodiments have incorporateda tube, but the invention can also be enjoyed with a catheter having ashaft formed to accommodate external urine flow. Also, the variousembodiments utilizing sleeves have described the sleeve as beingattached to the funnel, or to the introducer tip or port, or to both.However, it will be appreciated that yet another possibility is for thesleeve to be disposed about the tube or shaft in such a manner that itis not attached to the catheter. Finally, this invention allowsdesirable designs and design features wherein the liquid water isincapable of reliably hydrating the catheter by direct liquid contact.

It will be seen that the present invention provides a fully lubriciousvapor hydrated hydrophilic coated catheter which is ready for use,provides no risk of liquid spillage, and may utilize an advantageoussleeve. The sleeve protects the catheter from finger touch andcontamination, and provides a reliable, non-slip gripping surface. Italso extends the time the catheter can be out of its packaging andexposed to air to thereby ensure against premature drying and loss oflubricity. The sleeve further offers essentially no resistance to theadvancement of the catheter into the body as the sleeve accordions orbunches against the catheter funnel during insertion. With the presentinvention, a vapor hydrated hydrophilic catheter has been provided thatnot only achieves all of these objectives, but it does so with a productthat is inexpensive to manufacture and easy to use.

While in the foregoing there have been set forth preferred embodimentsof the invention, the details herein given may be varied by thoseskilled in the art without departing from the true spirit and scope ofthe appended claims.

1.-113. (canceled)
 114. A packaged ready-to-use vapor hydratedhydrophilic product, comprising: a gas impermeable package containing: aproduct having a hydrophilic surface, and a vapor donating liquid,wherein the ready-to-use condition of the hydrophilic product is due atleast in part to the vapor donating liquid producing a vapor atmospherewithin the gas impermeable package that activates at least a portion ofthe hydrophilic surface.
 115. The packaged product of claim 114 whereinthe gas impermeable package has a sealed cavity and the hydrophilicproduct and the vapor donating liquid are contained within the sealedcavity.
 116. The packaged product of claim 115 wherein the vapordonating liquid is water comprising no more than about 20% of the volumeof the sealed cavity of the gas impermeable package.
 117. The packagedproduct of claim 115 wherein the vapor donating liquid is watercomprising no more than about 5% of the volume of the sealed cavity ofthe gas impermeable package.
 118. A packaged ready-to-use vapor hydratedhydrophilic product, comprising: a gas impermeable package containing: aproduct having a hydrophilic surface, a vapor donating liquid, and aliquid sequestering element, wherein the vapor donating liquid issubstantially retained by the liquid sequestering element to minimize aspill hazard, while releasing a vapor to produce a vapor atmospherewithin the package such that the ready-to-use condition of thehydrophilic product is due at least in part to the vapor activating atleast a portion of the hydrophilic surface, so as to ensure delivery ofthe hydrophilic product to the user in a completely ready-to-usecondition.
 119. The packaged product of claim 118 wherein the liquidsequestering element is formed of a fabric or foam capable of absorbingsubstantially all of the available vapor donating liquid and thenreleasing a vapor from the vapor donating liquid to produce and maintaina fully saturated vapor atmosphere in a state of equilibrium within thegas impermeable package.
 120. A packaged ready-to-use vapor hydratedhydrophilic product manufactured by a process comprising the steps of:providing a gas impermeable package having a cavity therein; placing ahydrophilic product in the cavity of the package; placing a vapordonating liquid in the cavity of the package; sealing the cavity of thepackage with the hydrophilic product and the vapor donating liquidtherein; and delaying distribution of the package after sealing thecavity with the hydrophilic product and the vapor donating liquidtherein for a period of time sufficient: i) for the vapor donatingliquid to produce a vapor atmosphere within the cavity; and ii) for thevapor atmosphere to complete the activation of the hydrophilic product.121. The packaged product of claim 120 wherein the vapor donating liquidis water comprising no more than 20% of the volume of the sealed cavityof the gas impermeable package.
 122. The packaged product of claim 120wherein the vapor donating liquid is water comprising no more than about5% of the volume of the sealed cavity of the gas impermeable package.123. The packaged product of claim 120 where the distribution of the gasimpermeable package is delayed for a determinable period of time ofbetween 1 and 45 days to ensure complete vapor hydration of thehydrophilic product in the package.
 124. A packaged ready-to-use vaporhydrated hydrophilic product, comprising: a gas impermeable packagecontaining: a hydrophilic product, and a vapor donating liquid, suchthat the vapor donating liquid in the package is incapable of reliablyhydrating the hydrophilic coated product by direct liquid contact, andwherein the vapor donating liquid produces a vapor atmosphere within thepackage to activate at least a portion of the hydrophilic product, toensure delivery of the hydrophilic product to the user in a completelyready-to-use condition.
 125. The packaged product of claim 124 whereinthe vapor donating liquid is water comprising no more than about 20% ofthe volume of the sealed cavity of the gas impermeable package.
 126. Thepackaged product of claim 124 wherein the vapor donating liquid is watercomprising no more than about 5% of the volume of the sealed cavity ofthe gas impermeable package.
 127. The packaged product of claim 124including a liquid sequestering element disposed within the sealedcavity of the gas impermeable package for minimizing a spill hazard.128. A method of producing a packaged ready-to-use vapor hydratedhydrophilic coated product comprising the steps of: providing a gasimpermeable package having a cavity therein; coating at least a portionof a product with a hydrophilic coating; placing the hydrophilic coatedproduct in the cavity of the package; placing a vapor donating liquid inthe cavity of the package; sealing the cavity of the package with thehydrophilic coated product and the vapor donating liquid therein;delaying distribution of the package after sealing the cavity with thehydrophilic coated product and the vapor donating liquid therein for aperiod of time sufficient: i) for the vapor donating liquid to produce avapor atmosphere within the cavity; and ii) for the vapor atmosphere tocomplete the activation of the hydrophilic coated product.
 129. Themethod of claim 128 wherein the vapor donating liquid is watercomprising no more than about 20% of the volume of the sealed cavity ofthe gas impermeable package.
 130. The method of claim 128 wherein thevapor donating liquid is water comprising no more than about 5% of thevolume the sealed cavity of the gas impermeable package.
 131. The methodof claim 128 wherein the distribution of the gas impermeable package isdelayed for a determinable period of time of between 1 and 45 days toensure complete vapor hydration of the hydrophilic coated product. 132.The method of claim 128 including the step of placing a liquidsequestering element in the cavity of the gas impermeable package forabsorbing the vapor donating liquid and producing a vapor atmospheretherein.
 133. A method for ensuring delivery of a hydrophilic product toan end user in a completely ready-to-use condition, comprising the stepsof: providing the hydrophilic product within a gas impermeable packagetogether with a vapor donating liquid; determining the times requiredfor: i) the vapor donating liquid to form a vapor atmosphere in a stateof equilibrium within the gas impermeable package; and ii) the vapordonating liquid to complete the activation of the hydrophilic productwithin the gas impermeable package; and delaying the distribution of thehydrophilic product to the end user for at least the longer of the timesso determined; whereby the hydrophilic product is in a completelyready-to-use condition when it is delivered to the end user.
 134. Thehydrophilic product delivery method of claim 133 wherein the hydrophilicproduct is completely hydrated in the gas impermeable package by thevapor atmosphere that is formed by the vapor donating liquid.
 135. Thehydrophilic product delivery method of claim 133 wherein the vapordonating liquid is water comprising no more than about 20% of the volumeof the sealed cavity of the gas impermeable package.
 136. Thehydrophilic product delivery method of claim 133 wherein the vapordonating liquid is water comprising no more than about 5% of the volumeof the sealed cavity of the gas impermeable package.
 137. Thehydrophilic product delivery method of claim 133 wherein thedistribution of the gas impermeable package is delayed for adeterminable period of time of between 1 and 45 days to ensure completevapor hydration of the hydrophilic product.
 138. The hydrophilic productdelivery method of claim 133 including the step of placing a liquidsequestering element in the cavity of the gas impermeable package forabsorbing the vapor donating liquid and producing a vapor atmospheretherein.
 139. A packaged ready-to-use vapor hydrated hydrophilicproduct, comprising: a gas impermeable package containing a hydrophilicproduct wherein the package contains a vapor donating liquid, andwherein the ready-to-use condition of the hydrophilic product is due atleast in part to the vapor donating liquid producing a vapor atmospherewithin the package that activates at least a portion of the hydrophilicproduct.
 140. A packaged hydrophilic product comprising a gasimpermeable package containing a product having a hydrophilic coatedportion, a liquid, and a gas permeable, liquid impermeable filmseparating the liquid from at least the hydrophilic coated portion ofthe product.
 141. The packaged hydrophilic product of claim 140 whereinthe liquid is contained within a liquid sequestering element and the gaspermeable, liquid impermeable film is between the liquid sequesteringelement and the hydrophilic coated portion of the product.